Daniel Paproth
On March 22, 2019
‘We’re quietly confident’: ResApp on European, US approvalResApp, Prime Minister? Picture: Getty Images
Medical device hopeful
ResApp Health (ASX:RAP) says it is “quietly confident” of getting approval for its coughing app from European and American regulatory bodies, as it waits on the precipice of a make-or-break moment.
ResApp makes a smartphone app that helps clinicians diagnose respiratory diseases in children, and it is hoping that it will soon be able to sell its product to doctors.
The company submitted its application for the CE Mark, the European gold standard, in January, and is in the final stages of preparing its submission to the US Food and Drug Administration (FDA).
If successful, it means the company will be able to market a product that can diagnose lower respiratory tract disease, asthma and reactive airway disease and primary upper respiratory tract disease.
It is a critical moment — approvals could bring in plenty of money, but if the answer is neutral or, even worse, a no, it would be nothing short of a disaster.
But Tony Keating, ResApp chief, said he was as certain as he could be his company would get a yes.
“We’ve done a lot of hard work, we’ve got great clinical data, we’ve been working with experienced consultants who know how to file a submission and have a good handle on how likely one is to succeed, and we’re feeling quietly confident,” he told
*.
“A rejection from both would be a challenge for us no doubt, but we really don’t think that’s likely given all the work we have put in so far. And they don’t tend to reject on the first submission anyway, it tends to be a conversation, not an outright no.
“I think we’re in with a very good shot, we are due to hear about the CE Mark imminently and hopefully we will soon be opening up the US and European markets and marketing and selling into them.”
The company is also developing an
obstructive sleep apnoea screening testusing a smartphone to diagnose snoring from a bedside table, which Mr Keating told
* had generated good early results.
“So even if we did get a no from the regulatory bodies we still have adult coughing data and sleep apnoea data to fall back on,” he said.
“The data from the sleep lab has been positive, but now we need to answer the question does it work as well in the home setting, and that’s what we are in the process of finding out right now.”
Xanadu’s Mongolian copper-gold venture showing a heap of potential »« Mineral sands producer Melior is still keen on shifting from Canada to OzCategories: Health & Biotech
Related Post- Sleep-deprived dentist: ‘I knew it worked when my wife thought I was dead’
A Brisbane dentist with sleep apnoea who felt like he was “being gassed” when wearing…
- Home diabetes test aimed at Australia’s 500,000 undiagnosed cases
A home diabetes detection test promises to reduce an estimated 500,000 cases of undiagnosed cases…
- Dr Graham Kelly’s Noxopharm expects NOX66 cancer drug trial results by Christmas
Not many medical researchers have more incentive than Dr Graham Kelly. While working to develop…
*All Rights Reserved
Top |
View Non-AMP VersionABOUT USMEET THE TEAMCONTACT USADVERTISE* is providing factual information where there is a reasonable likelihood of doubt.
The information is not intended to imply any recommendation or opinion about a financial product.
Terms of usePrivacy PolicyCopyright 2019
